Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

Official Title ICMJE

SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

Brief Summary

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Detailed Description

This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.

For the purpose of this substudy, patients will be followed up for a period of 12 months.

The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:

Echocardiogram (for both groups)

cMRI (for both groups)

PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)

Patients randomised to therapygroup should use the device each night at least 3 hours

Other Name: Adaptive Servo-Ventilation with AutoSet CS

Study Arm (s)

Active Comparator: Therapy with adaptive servo ventilation

optimal medical therapy + adaptive servoventilation

Intervention: Device: adaptive servoventilation (ASV)

No Intervention: Optimal medical therapy according to guidelines

optimal medical therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Estimated Enrollment ICMJE

300

Estimated Completion Date

May 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE−HF. The inclusion and exclusion criteria are listed here.

INCLUSION CRITERIA FOR SERVE-HF STUDY:

Over 22 years of age

Severe Chronic Heart Failure (CHF) with NYHA class III−IV or NYHA class II with at least one hospitalisation for HF within the last 24 months

Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation

Diagnosis of sleep disordered breathing (SDB) with an apnoea−hypopnoea−index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr

Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month

Optimised medical treatment according to the applicable guidelines

Able to provide informed consent

ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY

• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula